How to Respond to Conditional Re-Approval
At the time of continuing review, the IRB may determine that revisions or additional clarifications are needed from the study team prior to granting full re-approval of the study. This is called Conditional Reapproval. The IRB will not grant full re-approval or release a stamped consent form for continuation of enrollment until all stipulations have been appropriately addressed. A conditional re-approval may be issued for any continuing review regardless of study risk level.
What Actions are Required due to a Conditional Re-Approval Determination?
When the IRB issues a conditional re-approval:, all study activities may continue as planned for subjects who are already enrolled. However, enrollment of new subjects is not permitted. If the study is closed to enrollment, the Board’s conditions should still be addressed to maintain regulatory compliance, even if a stamped consent form may not be needed.
How to Submit a Response to Conditional Re-approval
Studies in HSERA
The continuing review submission will not be returned to you. Please download and complete a modification form (available on the IRB website). Then create and submit a modification via HSERA with the required documents attached.
Paper Studies
Please download and complete a modification form (available on the IRB website). Then submit copies of all required documents to the IRB office via IRB PO Box.
Response Requirement
- A cover letter with a response to each stipulation
- A document list for documents included in the response
- Tracked versions of all documents for which the IRB stipulated revisions, demonstrating the requested changes
- Clean versions of all updated documents
- Another other documentation requested by the Committee (e.g., sponsor communication, medical monitor or DSMB report, etc.)
Cover Letter Instructions
Please follow these steps to improve the IRB’s ability to quickly process your response.
- In the response cover letter please directly state, “This is a response to stipulations raised by the IRB on [Date] for a continuing review submission [Confirmation code if applicable].”
- The response cover letter should include individual responses to all stipulations raised. The IRB stipulations should appear as written in the conditional re-approval letter. A narrative response after each stipulation should be provided with references to locations of related changes or requested info.
- NOTE: If any directive stipulation from the IRB will not be followed, please state that clearly in your response and provide rationale. If any stipulations are not clearly addressed, the submission may be returned to the study team for completion.
- The response cover letter should clearly demonstrate the IRB’s stipulations and the study teams responses. Alternating colors are not required but are often helpful. For example:
- Stipulation as phrased by the IRB
Response: Detailed narrative response - Stipulation as phrased by the IRB
Detailed narrative response
- Stipulation as phrased by the IRB
If you intend to include new changes to the HS-ERA Application (e.g.., addition or removal of study personnel) or new documents (e.g.., a new questionnaire) with the response to stipulations, your cover letter should clearly outline in a separate section, the additional changes that are included and do not pertain to the stipulations.
Note: The IRB does not recommend including new changes when responding to stipulations as it may further delay the re-approval of the protocol.